Job Description

JOB PURPOSE

The PTO Senior Process Engineer provides technical supply support on the commercialization and manufacture of all drug products either independently or with minimal support (seeking support/ escalating efficiently where needed). He/ She supports/ leads all technical/ process activities (for example) investigations, validation and qualification processes, risks assessments, process safety management activities under his/ her responsibilities and could be responsible for technical product stewardship activities. The PTO Senior Engineer also supports continuous process improvement activities to enhance site performance metrics and contributes to the global technical network to share site experiences/ knowledge and continuously expands on personal expertise. He/ She is also supports/leads the introduction of new products to the site and the transfer of drug products to other facilities. The PTO Senior Process Engineer supports the objectives of his/her senior/ direct supervisor.

MAIN RESPONSIBILITIES

• Supports or leads (with minimal guidance) new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Demonstrates strength in technical writing for change request, PPQ reports and CMC sections.

• Is involved in/ supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for process/ processes to evaluate the impact of proposed changes to validated equipment/ processes. Proactively identify solutions with support from seniors or direct supervisor to address issues that are occurring experiment/evaluation.

• Provides technical guidance in support of site and divisional capital projects and new facility start-up activities. Ensures that the process design is well thought-out and robust for routine manufacturing. Provide technical input independently to the process design to ensure its fit for purpose for routine manufacturing. Responsible to transfer the knowledge of the project and facility to IPT colleagues.

• Provides technical expertise related to the product, equipment and manufacturing/ cleaning processes in response to deviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventative actions.

• Provides technical expertise for compliance activities such as audit and regulatory support. Monitors and addresses potential regulatory risks during various phases of the lifecycle process independently or as part of a team.

• Supports and manages product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g., SOPs, batch/ records, recipes), quality risk assessments, change control management (filing support (if applicable) and validation activities such as equipment qualification, simple process validation and cleaning validation/ monitoring activities. Expected to have a working knowledge of respective compliance topics related to the above-mentioned activities and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.

• Supports routine supply manufacturing by providing on going technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve issues in production systems.

• Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. This could involve leading/participating in Prospective Process Analyses (PPA), statistical analysis and response to shifts and trends in process performance. Where applicable (under the guidance of colleague if necessary), undertakes responsibilities as an active site product steward and is a member of the Value Chain Technical Team.

• In addition, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management. Applies moderately complex statistical and risk analysis tools to evaluate actions required to ensure product robustness across applicable manufacturing equipment and processes.

• Demonstrates good understanding of product CPP, CQA, Cpk and sterile boundary of the current validated processes. Have good knowledge of the raw materials and PCC (product contact components) used for the products under his/her responsibility.

• Actively participates and shows commitment to collaboration and sharing of best practices across the global S&T network.

• Complies with all divisional and site-specific policies, guidelines and procedures.

• Demonstrates and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are carried out in accordance with EHS requirements. Actively participates in GEMBA safety walks. Participates in or leads process hazards analyses (PHA) and applicable Process Safety Management (PSM) activities related to new/line products.

• Where applicable, develops SOPs, gap analyses and procedures for Quality/EHS subsystems/ topics in compliance with regulatory requirements, divisional and corporate policies and guidelines.

• Demonstrates leadership behaviors in alignment with leadership standards (Individual Contributor). Practices inclusion as the How.

• Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.

• Any other duties as assigned by the Supervisor.

PROFILE:

Qualification: Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences, or Pharmaceutical Sciences

Experience: Minimum 2 years technical experience in pharmaceutical manufacturing industry

Leadership

Required Skills:

Adaptability, Adaptability, Aviation Safety Management, Biomedical Sciences, Capital Projects, Career Development, cGMP Guidelines, Change Control Processes, Electronic Batch Records, Laboratory Experiments, Mammalian Cell Culture, Manufacturing Support, Mechatronics, Personal Initiative, Pharmaceutical Manufacturing, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Product Lifecycle, Product Portfolio Management, Regulatory Requirements, Regulatory Risk, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing {+ 2 more}

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/8/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.